Hiring Manager: Kok Yong Theo
Recruiter: Aislinn Roche

ABOUT THE ROLE

As Senior Quality Assurance Manager, you will lead the Quality Management System for Australia and New Zealand and serve as the ANZ Quality Management Representative. You will provide strategic and operational leadership across quality assurance activities, lead a team of quality professionals, and partner with business leaders both locally and regionally to drive compliance, continuous improvement, patient safety and customer outcomes. 

This role is based in Mascot, Sydney and will report to the Quality Assurance Director, APAC.

KEY RESPONSIBILITIES

• Lead and continuously improve the ANZ Quality Management System in line with ISO 13485, ISO 9001, local requirements and company policies. 

• Oversee audit readiness, management review, quality objectives, metrics, reporting and quality improvement projects. 

• Provide quality oversight across operations, supply chain, distribution, suppliers, post-market activities, document control, training and risk management. 

• Ensure nonconformances, CAPAs, deviations, complaints, field actions and changes are managed effectively. 

• Use quality data and risk-based thinking to identify issues, strengthen processes and support sound business decisions. 

• Partner with leaders and employees to translate quality requirements into clear, practical guidance. 

• Build effective relationships with customers, suppliers, distributors and relevant authorities, working with Regulatory Affairs and other accountable teams where required. 

• Represent ANZ Quality Assurance in local, regional and global forums, escalating significant risks and recommending practical solutions. 
• Maintain compliance with the Quality Policy and applicable quality processes, ensure the team has the resources needed to support the QMS, and promote a work environment that supports relevant Environment, Health and Safety and Energy policies. 
• As part of the APAC QA Leadership team, engage in quality related affairs, issues and projects within the APAC region through various forums.

People Leadership and Business Partnership 

• Lead, coach and develop the Quality team, setting clear priorities, goals and development plans. 

• Oversee team resourcing, recruitment, budget, succession and performance management. 

• Create an inclusive and accountable environment where people feel empowered to raise concerns and improve how work is done. 

• Position Quality Assurance as a trusted business partner, balancing commercial priorities with independent quality judgement. 

• Lead cross-functional improvement initiatives that enhance compliance, reduce risk and deliver measurable value. 

KEY COMPETENCIES REQUIRED FOR SUCCESS

People Development

• Attracts, develops, manages and retains talent through providing employees with continuous feedback, mentoring, coaching, training and actively seeking development opportunities to compliment existing skill sets
• Holds self and others accountable for making continuous progress against development objectives
• Upholds our values of High Performance and Caring by developing talent to meet commercial goals while respecting individual differences

Relationship Building

• Builds and maintains effective external as well as internal networks that add value in achieving work related goals.
• Skilled in building rapport with a wide variety of individuals with diverse backgrounds and ways of thinking

Collaboration & Communication

• Models and promotes collaboration and works effectively with others to achieve goals.  Involves others, where appropriate, in decision making.
• Creates an environment which promotes honest and open communication and information sharing amongst the team and organisation.
• Listens actively and encourages expression of ideas and opinions.

Global Perspective

• Keeps abreast of important trends both locally and globally that impact the business or organization.  Understands the position of the organization within the APAC context, adopts and helps others to adopt a regional/global approach.
• Identifies the unique business and cultural challenges and/or constraints involved when conducting business globally. 

Influence & Adaptability 

• Influences and motivates others.  Wins support and acceptance for proposed changes and ideas through consideration of key stakeholder needs. 

• Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations.
• Moves forward productively and optimistically under conditions of change and uncertainty.

Execution

• Drives results by assigning clear authority and accountability, integrating and aligning efforts across units and functions, and monitoring progress against objectives. Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance. 
• Addresses problems directly and drives changes necessary to achieve business objectives.  

YOUR EXPERIENCE AND SKILLS

• Bachelor's degree in Science, Engineering, Health Sciences, Pharmacy, Biomedical Engineering, Quality
• Demonstrated experience in quality management within a regulated healthcare, medical device, pharmaceutical, biotechnology, or similar environment.
• Proven people leadership experience, including leading and developing high-performing teams.
• Experience leading Quality Management Systems, compliance activities, audit readiness, and continuous improvement initiatives.
• Lead Auditor qualification and/or extensive experience working within ISO 13485 and ISO 9001 environments, including the leadership of CAPA processes, root cause investigations and corrective action programs.
• Experience across quality systems, supplier quality, quality operations, and post-market quality activities.
• Ability to manage multiple priorities and influence diverse stakeholders across functions and geographies.
• Strong analytical, problem-solving, influencing, and communication skills.
• Willingness to travel within Australia, New Zealand, and internationally as required.

WHY CHOOSE US?

• Great Place To Work Certified in 2024 & 2025
• Best Workplaces for Women in 2024 & 2025
• Inclusive Employee Resource Groups
• 2 Wellbeing Days per year
• Discounted health insurance
• Ability to purchase additional Annual Leave
• Employee Stock Purchase Plan
• Access to Employee Assistance Program

Requisition ID: 633079